Chondroitin Sulfate Injection Grade | Runxin 28 Years Sterile Production

Manufacturer Profile: Runxin – Sterile Manufacturing Excellence Since 1998
Runxin brings 28 years of specialized expertise in sterile-grade chondroitin sulfate production for injectable applications. Our dedicated aseptic manufacturing facilities maintain comprehensive international certifications including cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, and FSSC22000, with particular emphasis on sterile pharmaceutical manufacturing standards. Serving global pharmaceutical companies and medical device manufacturers across 70+ countries, we combine advanced aseptic processing technologies with rigorous sterility assurance programs to deliver injection-grade chondroitin sulfate of exceptional purity and safety for parenteral applications.

Product Overview: Injection Grade Chondroitin Sulfate
Runxin's Injection Grade Chondroitin Sulfate is manufactured under strict aseptic conditions specifically for parenteral formulations and medical device applications. This sterile-grade material undergoes comprehensive purification including ultrafiltration, endotoxin removal, and terminal sterilization to meet stringent injectable quality standards. With purity levels exceeding 98% and endotoxin limits below 0.05 EU/mg, our product ensures the highest level of safety and compatibility for intravenous, intramuscular, and intra-articular administration.

Key Advantages

• Sterile Assurance: Manufactured in EU Grade A/B cleanroom environments

• Ultra-Low Endotoxin: Endotoxin levels <0.05 EU/mg

• Pyrogen-Free: Validated pyrogen removal processes

• Particle Control: Strict sub-visible particulate matter monitoring

• Regulatory Compliance: Meets USP <71> and EP 2.6.1 sterility requirements

Technical Specifications

• Appearance: White sterile lyophilized powder

• Purity: ≥98% (HPLC)

• Molecular Weight: 16,000-25,000 Da

• Endotoxin Level: <0.05 EU/mg

• Sterility Testing: Meets USP <71> and EP 2.6.1

• Particulate Matter: Meets USP <788> requirements

• Protein Content: ≤0.5%

• Heavy Metals: ≤2 ppm

• pH (1% solution): 6.5-7.5

• Bacterial Endotoxins: <0.05 EU/mg

• Solubility: ≥99% in WFI

• Certifications: cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, FSSC22000

Applications

• Intra-articular injections for osteoarthritis treatment

• Viscosupplementation products

• Ophthalmic surgical viscoelastic solutions

• Wound healing and tissue regeneration products

• Advanced drug delivery systems

• Medical device coatings and formulations

FAQs About Injection-Grade Chondroitin Sulfate

1. What specific quality parameters differentiate injection-grade from oral-grade chondroitin sulfate?
   Injection-grade requires sterility assurance, endotoxin levels below 0.05 EU/mg, pyrogen-free status, controlled sub-visible particulate matter, and compliance with pharmacopeial sterility tests (USP <71>, EP 2.6.1), along with complete documentation of aseptic processing and container-closure integrity.

2. How does your sterile manufacturing process ensure product safety for injection?
   Our 28 years of sterile manufacturing expertise includes terminal sterilization validation, aseptic processing in EU Grade A/B environments, comprehensive environmental monitoring, media fill validation, and rigorous container-closure integrity testing to ensure sterility throughout the product lifecycle.

3. What documentation do you provide for injectable product regulatory submissions?
   We supply complete regulatory documentation including Drug Master Files, sterility validation reports, endotoxin testing data, particulate matter monitoring records, container-closure integrity studies, and all required certification documents (cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, FSSC22000) for global regulatory submissions.

4. Can you provide customized molecular weight profiles for specific injectable applications?
   Yes, with our 28 years of specialized experience, we offer tailored molecular weight ranges (10,000-30,000 Da) optimized for specific applications such as intra-articular injections requiring specific viscoelastic properties or ophthalmic applications needing precise rheological characteristics.

5. How do you manage endotoxin control throughout the manufacturing process?
   Our comprehensive endotoxin control strategy includes raw material screening, process water validation (WFI system), depyrogenation processes, in-process testing, and final product release testing using LAL methodology, ensuring consistent compliance with injectable-grade endotoxin limits.

Why Choose Runxin for Injection-Grade Requirements

• 28 Years of Sterile Manufacturing: Specialized expertise in aseptic processing since 1998

• Complete cGMP Compliance: Full adherence to sterile pharmaceutical manufacturing standards

• Global Regulatory Success: Proven track record with international health authorities

• Quality Assurance Excellence: Comprehensive sterility and pyrogen control programs

• Technical Partnership: End-to-end support from formulation to commercial manufacturing

Partner with Sterile Manufacturing Specialists
Choose Runxin for your injection-grade chondroitin sulfate requirements and leverage our 28 years of sterile manufacturing excellence. Contact us today to request samples, regulatory documentation, or discuss your specific injectable application needs. Experience the confidence that comes with working with a proven supplier of sterile-grade chondroitin sulfate with demonstrated regulatory compliance and uncompromising quality standards for parenteral applications.